CN111386086A - System and method for cleaning endoscopic instruments - Google Patents

Abstract

This invention describes a method for controlling fluid delivery to a conduit, comprising filling a reservoir of known size with fluid to a volume having an initial fluid pressure, and releasing a discharge fluid volume from the reservoir into the conduit. The method further includes measuring the discharge fluid volume and determining a discharge fluid volume through the conduit based on the discharge fluid volume and the discharge fluid volume.

Description

System and method for cleaning endoscopic instruments

CROSS-REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of US Provisional Application 62/585922, filed November 14, 2017, which is incorporated by reference in its entirety.

technical field

The present invention relates to systems and methods for controlling steerable elongated devices.

Background technique

Minimally invasive medical techniques are designed to reduce the amount of damaged tissue in medical procedures, thereby reducing patient recovery time, discomfort and harmful side effects. This minimally invasive technique can be performed through a natural orifice in the patient's anatomy or through one or more surgical incisions. Through these natural orifices or incisions, the operator can insert minimally invasive medical tools to reach the target tissue location. Minimally invasive medical tools include therapeutic, diagnostic, biopsy and surgical instruments. Minimally invasive medical tools may also include imaging instruments, such as endoscopic instruments. The imaging instrument provides the user with a view within the patient's anatomy. Some minimally invasive medical tools and imaging instruments may be teleoperated or computer-assisted. In order to provide a clear view, the imaging device should be free of debris or other material that would obstruct the view. A system and method for cleaning an imaging device as it is inserted into a patient's anatomy is required.

SUMMARY OF THE INVENTION

Embodiments of the invention are best summarized in the claims annexed to the specification.

Consistent with some embodiments, a method for controlling fluid delivery to a catheter includes charging a reservoir of known size to a volume with fluid at an initial fluid pressure and releasing a desired release fluid volume of fluid from the reservoir to the catheter. The method also includes measuring the exhaust fluid volume and determining the exhaust fluid volume through the conduit based on the released fluid volume and the exhaust fluid volume.

According to some embodiments, a system for controlling fluid delivery to a catheter includes a fluid reservoir and a valve system, the fluid reservoir having a known size and charged with fluid at an initial fluid pressure to an initially known fluid volume, and a valve system is coupled between the fluid reservoir and the conduit. The system also includes a vent, a flow sensor coupled between the valve system and the vent, and a control system including one or more processors. The control system is configured to actuate the valve system to release the discharge fluid volume from the fluid reservoir to the conduit, measure the discharge fluid volume through the discharge port with the flow sensor, and determine the discharge through the conduit based on the discharge fluid volume and the discharge fluid volume fluid volume fluid.

It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide an understanding of the invention and not to limit the scope of the invention. In this regard, additional aspects, features and advantages of the present invention will become apparent to those skilled in the art from the following detailed description.

Brief Description of Drawings

1 is a simplified diagram of a teleoperated medical system in accordance with some embodiments.

2A is a simplified diagram of a medical device system in accordance with some embodiments.

2B is a simplified diagram of a medical device with an extended medical tool, according to some embodiments.

3A and 3B are simplified diagrams of side views of a patient coordinate space including a medical instrument mounted on an insert assembly, according to some embodiments.

4 is a cross-sectional view of the distal end of the imaging instrument positioned within the distal end of the catheter to form a fluid distribution path.

Figure 5 illustrates a fluid delivery system according to some embodiments.

6 illustrates a medical device system according to some embodiments.

FIG. 7 shows a graph of pressure variation in a fluid reservoir of the fluid delivery system of FIG. 5 .

Figure 8 illustrates a method of controlling the delivery of fluid to a medical device.

Figure 9 illustrates a method of tracking fluid discharge volume.

Figure 10 illustrates a method of assessing placement of an imaging instrument within an elongated flexible guide instrument.

Figure 11 illustrates a fluid delivery system according to some embodiments.

Embodiments of the present invention and their advantages will be best understood by reference to the following detailed description. It should be understood that like reference numerals are used to identify like elements shown in one or more of the figures for the purpose of illustrating embodiments of the invention and not for the purpose of limiting the same embodiments.

Detailed description

In the following description, specific details describing some embodiments consistent with the invention are set forth. Numerous specific details are set forth in order to provide a thorough understanding of the embodiments. It will be apparent, however, to one skilled in the art that some embodiments may be practiced without some or all of these specific details. The specific embodiments disclosed herein are illustrative, and not restrictive. Although not specifically described herein, those skilled in the art will recognize that other elements are within the scope and spirit of the invention. Furthermore, to avoid unnecessary repetition, one or more features shown and described in connection with one embodiment may be incorporated into other embodiments unless specifically stated otherwise or if one or more features doesn't work.

In some instances, well-known methods, procedures, components and circuits have not been described in detail so as not to unnecessarily obscure aspects of the embodiments.

The present invention describes various instruments and parts of instruments in terms of states in three-dimensional space. As used herein, the term "orientation" refers to the position of an object or a portion of an object in three-dimensional space (eg, three translational degrees of freedom along Cartesian x, y, and z coordinates). As used herein, the term "orientation" refers to the rotational placement of an object or a portion of an object (three rotational degrees of freedom, eg, roll, pitch, and yaw). As used herein, the term "pose" refers to the orientation of an object or a portion of an object in at least one translational degree of freedom and the orientation of the object or portion of an object in at least one rotational degree of freedom (up to six degrees of freedom). As used herein, the term "shape" refers to a set of poses, orientations, or orientations measured along an object.

1 is a simplified diagram of a teleoperated medical system 100 in accordance with some embodiments. In some embodiments, the teleoperated medical system 100 may be suitable for use in surgical, diagnostic, therapeutic or biopsy procedures, for example. While some examples of these procedures are provided herein, any reference to medical or surgical instruments and medical or surgical methods is non-limiting. The systems, apparatus, and methods described herein can be used in animals, human cadavers, animal cadavers, parts of human or animal anatomy, non-surgical diagnostics, and industrial systems and general-purpose robotic or teleoperated systems.

As shown in FIG. 1 , a medical system 100 generally includes a teleoperated manipulator assembly 102 for operating a medical instrument 104 to perform various procedures on a patient P. As shown in FIG. The telemanipulator assembly 102 is mounted on or near the operating table T. The main assembly 106 allows an operator O (eg, a surgeon, clinician, or physician, as shown in FIG. 1 ) to view the intervention site and control the telemanipulator assembly 102 .

The main assembly 106 may be located at an operator console that is generally located in the same room as the operating table T, eg, on the side of the operating table where the patient P is located. However, it should be understood that the operator O may be located in a different room than the patient P or in a completely different building. The main assembly 106 typically includes one or more control devices for controlling the teleoperated manipulator assembly 102 . Control devices may include any number of various input devices, such as joysticks, trackballs, data gloves, trigger guns, hand controls, voice recognition devices, body motion or presence sensors, and the like. In order to provide the operator O with a strong feeling of directly controlling the instrument 104 , the control device may have the same degrees of freedom as the associated medical instrument 104 . In this manner, the control device provides the operator O with the feeling that the telepresence or control device is integrated with the medical device 104 .

In some embodiments, the control device may have more or fewer degrees of freedom than the associated medical device 104 and still provide telepresence to the operator O. In some embodiments, the control device may optionally be a manual input device that moves in six degrees of freedom, which may also include an actuatable handle for actuating the instrument (eg, for closing the grasping jaws, Electrodes apply electrical potential, deliver drug therapy, etc.).

The teleoperated manipulator assembly 102 supports the medical device 104 and may include one or more kinematic structures of non-servo-controlled linkages (eg, one or more linkages that can be manually positioned and locked in place, commonly referred to as assembly structure) and a remote-operated manipulator. The telemanipulator assembly 102 optionally includes a plurality of actuators or motors that drive inputs on the medical device 104 in response to commands from a control system (eg, control system 112 ). The actuator optionally includes a drive system that, when coupled to the medical instrument 104, can advance the medical instrument into a natural or surgically created anatomical orifice. Other drive systems may move the distal end of the medical device 104 in multiple degrees of freedom, which may include three degrees of freedom of linear motion (eg, along the X, Y, Z Cartesian axes) and three degrees of rotational motion (e.g. rotation around X, Y, Z Cartesian axes). Additionally, an actuator may be used to actuate an articulatable end effector of the medical instrument 104 in order to grasp tissue in the jaws of a biopsy device and/or the like. Actuator orientation sensors, such as resolvers, encoders, potentiometers, and other mechanisms, may provide medical system 100 with sensor data describing the rotation and orientation of the motor shaft. This orientation sensor data can be used to determine the motion of the object manipulated by the actuator.

The teleoperated medical system 100 may include a sensor system 108 having one or more subsystems for receiving information about the instruments of the telemanipulator assembly 102 . These subsystems may include: orientation/position sensor systems (eg, electromagnetic (EM) sensor systems); for determining orientation along the distal end and/or one or more segments of the flexible body that may make up the medical device 104; A shape sensor system for orientation, velocity, velocity, posture, and/or shape; and/or an imaging system for acquiring images from the distal end of the medical device 104 .

The teleoperated medical system 100 also includes a display system 110 for displaying images or representations of the surgical site and medical instrument 104 generated by the subsystems of the sensor system 108 . Display system 110 and main assembly 106 may be oriented so that operator O can control medical device 104 and main assembly 106 with telepresence perception.

In some embodiments, medical instrument 104 may include components of an imaging system (discussed in greater detail below), which may include an imaging scope assembly or imaging instrument that records concurrent or real-time images of the surgical site, and which is passed through medical system 100 One or more displays of (eg, one or more displays of display system 110 ) provide images to the operator or operator O. The concurrent image may be, for example, a two-dimensional or three-dimensional image captured by an imaging instrument located within the surgical site. In some embodiments, the imaging system includes an endoscopic imaging instrument assembly that may be integrally or removably coupled to the medical instrument 104 . However, in some embodiments, a separate endoscope attached to a separate manipulator assembly may be used with the medical instrument 104 for surgical site imaging. In some examples, the imaging instrument alone or in combination with other components of the medical device 104 may be used when one or more lenses are partially and/or completely occluded by liquid and/or other materials encountered by the distal end of the imaging instrument, as described below. One or more mechanisms are included for cleaning one or more lenses of an imaging instrument. In some examples, the one or more cleaning mechanisms may optionally include an air and/or other gas delivery system that may be used to emit a blast of air and/or other gas to blow the one or more lenses clean. In International Publication No. WO/2016/025465, filed Aug. 11, 2016, disclosing "Systems and Methods for Cleaning an Endoscopic Instrument"; One or more cleaning mechanisms are disclosed in detail in US Patent Application 15/508,923 to Tools; examples of each of these patents are hereby incorporated by reference in their entirety. The imaging system may be implemented as hardware, firmware, software, or a combination that interacts with or otherwise executes one or more computer processors, which may include the processor that controls the system 112 .

Display system 110 may also display images of the surgical site and medical instruments captured by the imaging system. In some examples, the teleoperated medical system 100 may configure the controls of the medical instrument 104 and the main assembly 106 such that the relative orientation of the medical instrument is similar to the relative orientation of the operator O's eyes and hands. In this manner, the operator O can manipulate the medical instrument 104 and hand controls as if viewing the workspace in a substantially real presence. Real presence means that the presentation of the image is a real see-through image that simulates the perspective of an operator physically operating the medical device 104 .

In some examples, display system 110 may use data from imaging techniques such as computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermal imaging, ultrasound, optical coherence tomography (OCT), thermal imaging , impedance imaging, laser imaging, nanotube X-ray imaging, etc.) image data present images of the surgical site recorded preoperatively or intraoperatively. Preoperative or intraoperative image data may be presented as two-dimensional, three-dimensional, or four-dimensional (including, for example, time-based or velocity-based information) images, and/or as data from models generated from preoperative or intraoperative image datasets. image.

In some embodiments, the display system 110 may display a virtual navigation image, where the actual position of the medical instrument 104 is registered with the preoperative or concurrent images/models (ie, dynamic referencing), typically for purposes of image-guided surgery. Doing so may present the operator O with a virtual image of the internal surgical site from the perspective of the medical instrument 104 . In some examples, the viewing angle may be from the tip of the medical device 104 . An image of the tip of the medical device 104 and/or other graphical or alphanumeric indicators may be superimposed on the virtual image to assist the operator O in controlling the medical device 104 . In some examples, the medical instrument 104 may not be visible in the virtual image.

In some embodiments, the display system 110 may display a virtual navigation image in which the actual position of the medical instrument 104 is registered with the preoperative or concurrent images to present the operator O with a virtual image of the medical instrument 104 within the surgical site from an external perspective . An image of a portion of the medical device 104 or other graphical or alphanumeric indicator may be superimposed on the virtual image to assist the operator O in controlling the medical device 104 . As described herein, visual representations of data points may be presented to display system 110 . For example, measured data points, moved data points, registered data points, and other data points described herein may be displayed on display system 110 in a visual representation. Data points may be visually represented on the user interface by a plurality of dots or dots on the display system 110, or as a rendered model (eg, a grid or line model created based on a set of data points). In some examples, the data points may be color-coded according to the data they represent. In some embodiments, the visual representation may be refreshed in display system 110 after each processing operation is implemented to change a data point.

The teleoperated medical system 100 may also include a control system 112 . Control system 112 includes at least one memory and at least one computer processor (not shown) for controlling among medical device 104 , main assembly 106 , sensor system 108 and display system 110 . Control system 112 also includes programmed instructions (eg, a non-transitory machine-readable medium storing instructions) to implement some or all of the methods described in accordance with aspects disclosed herein, including instructions for providing information to display system 110 . Although the control system 112 is shown as a single block in the simplified schematic diagram of FIG. 1, the system may include two or more data processing circuits, a portion of which is optionally on the telemanipulator assembly 102 or Executes near it, another portion of the processing circuitry executes on the main assembly 106, and so on. The processor of the control system 112 may execute instructions, including instructions corresponding to the processes disclosed herein and described in greater detail below. Any of a variety of centralized or distributed data processing architectures may be employed. Similarly, the programmed instructions may be implemented as separate programs or subroutines, or they may be integrated into many other aspects of the remote operating system described herein. In one embodiment, the control system 112 supports wireless communication protocols such as Bluetooth, IrDA, HomeRF, IEEE802.11, DECT, and wireless telemetry.

In some embodiments, the control system 112 may receive force and/or torque feedback from the medical device 104 . In response to this feedback, the control system 112 may send a signal to the main assembly 106 . In some examples, control system 112 may send signals that instruct one or more actuators of telemanipulator assembly 102 to move medical instrument 104 . The medical device 104 may extend through an opening in the patient P body to an internal surgical site in the patient P body. Any suitable conventional and/or specialized actuators may be used. In some examples, one or more actuators may be separate or integrated with the telemanipulator assembly 102 . In some embodiments, one or more actuators and teleoperated manipulator assemblies 102 are provided as part of a teleoperated cart located near patient P and operating table T.

The control system 112 may optionally further include a virtual visualization system to provide navigation assistance to the operator O when controlling the medical instrument 104 in an image-guided surgical procedure. Virtual navigation using the virtual visualization system can refer to the acquired preoperative or intraoperative anatomical passage data sets. Virtual visualization systems process using techniques such as computed tomography (CT), magnetic resonance imaging (MRI), fluoroscopy, thermal imaging, ultrasound, optical coherence tomography (OCT), thermal imaging, impedance imaging, laser imaging, nanotube X An image of a surgical site imaged by imaging techniques such as radiography. Software, which can be used in conjunction with manual input, is used to convert the recorded images into a two-dimensional or three-dimensional composite representation of segments of part or the entire anatomical organ or anatomical region. Image datasets are associated with composite representations. Composite representations and image datasets describe the various locations and shapes of channels and their connectivity. In clinical procedures, preoperative or intraoperative recordings can be used to generate composite images. In some embodiments, the virtual visualization system may use standard representations (ie, not patient-specific) or a mix of standard representations and patient-specific data. The composite representation and any virtual images generated from the composite representation may represent the static pose of the deformable anatomical region during one or more phases of motion (eg, during the inspiratory/expiratory cycles of the lung).

In a virtual navigation procedure, the sensor system 108 may be used to calculate the approximate position of the medical instrument 104 relative to the patient P's anatomy. This position can be used to generate a macroscopic (external) tracking image of the patient P's anatomy and a virtual internal image of the patient P's anatomy. The system may implement one or more electromagnetic (EM) sensors, fiber optic sensors, and/or other sensors to match medical implementations with preoperatively recorded surgical images (eg, those known from a virtual visualization system) standard or together. For example, US Patent Application No. 13/107,562 (filed May 13, 2011) (published "Medical System Providing Dynamic Registration of aModel of an Anatomic Structure for Image-Guided Surgery"), incorporated herein by reference in its entirety, discloses one such system. The teleoperated medical system 100 may further include optional operating and support systems (not shown), such as lighting systems, steering control systems, irrigation systems, and/or suction systems. In some embodiments, the teleoperated medical system 100 may include more than one teleoperated manipulator assembly and/or more than one main assembly. The exact number of teleoperated manipulator assemblies will depend on the surgical procedure and space constraints in the operating room, among other factors. The main assemblies 106 may be juxtaposed, or they may be located in separate locations. Multiple main assemblies allow more than one operator to control one or more teleoperated manipulator assemblies in various combinations.

FIG. 2A is a simplified diagram of a medical device system 200 in accordance with some embodiments. In some embodiments, the medical device system 200 may be used as the medical device 104 in an image-guided medical procedure performed with the teleoperated medical system 100 . In some examples, the medical instrument system 200 may be used for non-teleoperated exploration procedures or procedures involving traditional manual medical instruments, such as endoscopy. Optionally, the medical device system 200 may be used to collect (ie, measure) a set of data points corresponding to locations within the anatomical passageway of a patient (eg, Patient P).

The medical device system 200 includes an elongated device 202, such as a flexible catheter, coupled to a drive unit 204. The elongated device 202 includes a flexible body 216 having a proximal end 217 and a distal or tip portion 218 . In some embodiments, the flexible body 216 has an outer diameter of about 3 mm. Other flexible outer diameters can be larger or smaller.

The medical device system 200 also includes a tracking system 230 to determine the position, orientation, velocity, velocity along the distal end 218 and/or one or more segments 224 of the flexible body 216 through the use of one or more sensors and/or imaging devices , posture and/or shape, as described in further detail below. The entire length of flexible body 216 between distal end 218 and proximal end 217 may effectively be divided into sections 224 . If the medical device system 200 is consistent with the medical device 104 of the teleoperated medical system 100, the tracking system 230 may optionally be implemented as hardware, firmware, software, or a combination thereof that interacts with one or more computer processors or otherwise The one or more computer processors may include the processor of the control system 112 in FIG.

Tracking system 230 may optionally use shape sensor 222 to track distal end 218 and/or one or more segments 224 . Shape sensor 222 may optionally include an optical fiber aligned with flexible body 216 (eg, disposed within an internal channel (not shown) or mounted externally). In one embodiment, the optical fiber has a diameter of about 200 μm. In other embodiments, the size may be larger or smaller. The optical fibers of shape sensor 222 form a fiber optic bend sensor for determining the shape of flexible body 216 . In one alternative, optical fibers including fiber Bragg gratings (FBGs) are used to provide strain measurements of the structure in one or more dimensions. In US Patent Application No. 11/180,389 (filed July 13, 2005) (disclosure "Fiberopticposition and shape sensing device and method relating thereto"), US Patent Application No. 12/047,056 (filed July 16, 2004) (disclosure "Fiber-optic shape and relative position sensing"), and US Patent No. 6,389,187 (filed June 17, 1998) (published "OpticalFiber Bend Sensor") describe various methods for monitoring the shape and relative orientation of optical fibers in three dimensions systems and methods, these applications are hereby incorporated by reference in their entirety. In some embodiments, the sensor may employ other suitable strain sensing techniques, such as Rayleigh scattering, Raman scattering, Brillouin scattering, and fluorescence scattering. In some embodiments, the shape of the elongated device may be determined using other techniques. For example, the history of the distal pose of the flexible body 216 can be used to reconstruct the shape of the flexible body 216 over that time period. In some embodiments, tracking system 230 may alternatively and/or additionally use position sensor system 220 to track distal end 218 . The orientation sensor system 220 may be a component of an EM sensor system, wherein the orientation sensor system 220 includes one or more conductive coils that may be subjected to externally generated electromagnetic fields. Each coil of the EM sensor system then generates an induced electrical signal having properties that depend on the orientation and orientation of the coil relative to the externally generated electromagnetic field. In some embodiments, the orientation sensor system 220 may be configured and positioned to measure six degrees of freedom (eg, three orientation coordinates X, Y, Z and three orientation angles to indicate pitch, yaw, and roll of the base point) ) or five degrees of freedom (eg, three azimuth coordinates X, Y, Z and two orientation angles to indicate pitch and yaw of the base point). A further description of the orientation sensor system is provided in US Patent No. 6,380,732 (filed August 11, 1999) (published "Six-Degree of Freedom Tracking System Having a Passive Transponder on the Object Being Tracked"), which is incorporated by reference in its entirety. into this article.

In some embodiments, tracking system 230 may alternatively and/or additionally rely on historical pose, orientation, or orientation data stored for known points of the instrument system along cycles of alternating motion (eg, breathing). This stored data can be used to develop shape information about the flexible body 216 . In some examples, a series of orientation sensors (not shown), such as electromagnetic (EM) sensors similar to those in orientation sensor 220, may be positioned along flexible body 216 and then used for shape sensing. In some examples, historical data acquired during the procedure from one or more of these sensors may be used to represent the shape of the elongated device 202, particularly where the anatomical passageway is generally static.

The flexible body 216 includes a channel 221 that is sized and shaped to receive a medical device 226 . 2B is a simplified schematic diagram of flexible body 216 with medical device 226 extended, according to some embodiments. In some embodiments, the medical device 226 may be used for procedures such as surgery, biopsy, ablation, irradiation, irrigation, or aspiration. The medical device 226 can be deployed through the channel 221 of the flexible body 216 and used at a target location within the anatomy. Medical instruments 226 may include, for example, image capture probes, biopsy instruments, laser ablation fibers, and/or other surgical, diagnostic or therapeutic tools. Medical tools may include end effectors having a single working member, such as scalpels, dull blades, optical fibers, electrodes, and the like. Other end effectors may include, for example, forceps, graspers, scissors, clip appliers, and the like. Other end effectors may further include electrically actuated end effectors such as electrosurgical electrodes, transducers, sensors, and the like. In various embodiments, medical device 226 is a biopsy device that can be used to remove sample tissue or sample cells from a target anatomical location. Medical instruments 226 may also be used within flexible body 216 with imaging instruments (eg, image capture probes). In various embodiments, the medical device 226 may itself be an imaging device (eg, an image capture probe) that includes a stereo camera at or near the distal end 218 of the flexible body 216 for capturing images, including video images or the distal portion of a monoscopic camera, the images are processed by imaging system 231 for display and/or provided to tracking system 230 to support tracking of distal end 218 and/or one or more segments 224 . The imaging instrument may include a cable coupled to the camera for transmitting captured image data. In some examples, the imaging instrument may be a fiber optic bundle, such as a fiberscope, coupled to imaging system 231 . Imaging devices may be mono- or multi-spectral, eg, collecting image data in one or more of the visible, infrared, and/or ultraviolet spectrums. Medical device 226 can be advanced from the opening of channel 221 to perform the procedure, and then retracted into the channel when the procedure is complete. The medical instrument 226 is removable from the proximal end 217 of the flexible body 216 or from another optional instrument port (not shown) along the flexible body 216 .

Additionally, the medical device 226 may also house a cable, linkage, or other actuation control device (not shown) extending between its proximal and distal ends to control the curved distal end of the medical device 226 . In US Patent No. 7,316,681 (filed October 4, 2005) (published "Articulated Surgical Instrument for Performing Minimally Invasive Surgery with Enhanced Dexterity and Sensitivity") and US Patent Application No. 12/286,644 (filed on September 30, 2008) (published Steerable instruments are described in detail in "Passive Preload and Capstan Drive for Surgical Instruments"), the text of which is incorporated herein by reference in its entirety.

The flexible body 216 may also accommodate cables, linkages, or other steering control devices (not shown) that extend between the drive unit 204 and the distal end 218 to controllably (eg, as shown by the dashed depiction 219 of the distal end 218 ) bend the distal end 218 . Shows). In some examples, at least four cables are used to provide independent "up and down" steering to control pitch of distal end 218 and "left to right" steering to control yaw of distal end 281 . Steerable elongated devices are described in detail in US Patent Application No. 13/274208 (filed October 14, 2011), which discloses "Catheter with Removable Vision Probe", which is incorporated herein by reference. In embodiments where the medical device system 200 is actuated by a teleoperated assembly, the drive unit 204 may include a drive input that receives power from a drive element (eg, an actuator) that is removably coupled to the teleoperated assembly . In some embodiments, the medical device system 200 may include gripping features, manual actuators, or other components for manually controlling the movement of the medical device system 200 . The elongated device 202 may be steerable, or alternatively, the system may be non-steerable without an integrated mechanism for the operator to control the bending of the distal end 218 . In some examples, one or more lumens are defined in the wall of the flexible body 216 through which a medical instrument can be deployed and used at a target surgical site.

In some embodiments, the medical device system 200 may include a flexible bronchial device, such as a bronchoscope or a bronchial catheter, for examination, diagnosis, biopsy, or treatment of the lung. The medical device system 200 is also suitable for navigating and treating various anatomical systems (including colon, intestine, kidney and calyx, brain, heart, circulatory system including vasculature and/or other organizations of any of the similar systems).

Information from the tracking system 230 may be sent to the navigation system 232 where it is combined with information from the imaging system 231 and/or preoperatively acquired models to provide real-time orientation information to the operator. In some examples, real-time orientation information may be displayed on display system 110 of FIG. 1 for control of medical device system 200 . In some examples, the control system 116 of FIG. 1 may utilize the orientation information as feedback for positioning the medical device system 200 . The use of fiber optic sensors to convert surgical Various systems for registration and display with surgical images, this patent is hereby incorporated by reference into this disclosure in its entirety.

In some examples, medical device system 200 may be remotely operated within medical system 100 of FIG. 1 . In some embodiments, the teleoperated manipulator assembly 102 of FIG. 1 may be replaced by direct operator control. In some examples, direct operator controls may include various handles and operator interfaces for handheld operation of the instrument.

3A and 3B are simplified schematic diagrams of side views of a patient coordinate space including a medical device mounted on an insert assembly, according to some embodiments. As shown in FIGS. 3A and 3B , surgical environment 300 includes patient P positioned on operating table 302 of FIG. 1 . Patient P may be stationary within the surgical environment in the sense that overall patient movement is limited by sedation, restraint, and/or other means. Periodic anatomical movements, including patient P's breathing and cardiac movements, may continue unless the patient is asked to hold his or her breath to temporarily suspend breathing movements. Thus, in some embodiments, data may be collected at a particular stage in respiration, marked and identified with that stage. In some embodiments, the stage at which the data was collected can be inferred from the physiological information collected from patient P. Within surgical environment 300 , point collection instrument 304 is coupled to instrument carrier 306 . In some embodiments, point collection instrument 304 may use EM sensors, shape sensors, and/or other sensor modalities. Instrument carrier 306 is mounted to insertion table 308 secured within surgical environment 300 . Alternatively, insertion table 308 may be movable, but have a known location within surgical environment 300 (eg, learned via tracking sensors or other tracking devices). Instrument carrier 306 may be a component of a telemanipulator assembly (eg, telemanipulator assembly 102 ) that is coupled to point collection instrument 304 to control insertion movement (ie, movement along the A axis) and may Movement of the distal end 318 of the elongated device 310 in multiple directions (including yaw, pitch and roll) is optionally controlled. The instrument carrier 306 or the insertion station 308 may include an actuator (not shown), such as a servomotor, that controls movement of the instrument carrier 306 along the insertion station 308 .

Elongated device 310 is coupled to instrument body 312 . The instrument body 312 is coupled and fixed relative to the instrument carrier 306 . In some embodiments, fiber optic shape sensor 314 is affixed to instrument body 312 at proximal end 316 . In some embodiments, proximal end 316 of fiber optic shape sensor 314 may move with instrument body 312, but the location of proximal end 316 may be known (eg, by a tracking sensor or other tracking device). Shape sensor 314 measures the shape from proximal point 316 to another point (eg, distal end 318 of elongated device 310). Point collection instrument 304 may be substantially similar to medical instrument system 200 .

The orientation measurement device 320 provides information about the orientation of the instrument body 312 as the instrument body 312 moves along the insertion axis A on the insertion station 308 . The orientation measurement device 320 may include resolvers, encoders, potentiometers, and/or other sensors that determine the rotation and/or orientation of the actuators that control the movement of the instrument carrier 306 and thus the movement of the instrument body 312 . In some embodiments, the insertion stage 308 is linear. In some embodiments, the insertion table 308 may be arcuate, or have a combination of arcuate and linear sections.

FIG. 3A shows the instrument body 312 and the instrument carrier 306 in a retracted orientation along the insertion table 308 . In this retracted orientation, proximal point 316 is at orientation L ₀ on axis A. At this orientation along insertion table 308, the A-component of the position of proximal point 316 may be set to zero and/or another reference value to provide a reference to describe the orientation of instrument holder 306 on insertion table 308, and The orientation of the proximal point 316 . With the instrument body 312 and instrument carrier 306 in this retracted orientation, the distal end 318 of the elongated device 310 may be positioned just inside the patient P's access port. Also in this orientation, the orientation measurement device 320 may be set to zero and/or another reference value (eg, I=0). 3B, the instrument body 312 and the instrument carrier 306 have been advanced along the linear trajectory of the insertion table 308, and the distal end 318 of the elongated device 310 has been advanced into the patient P. In FIG. In this advanced position, proximal point 316 is at orientation L1 _on axis A. In some examples, encoders and/or other orientation data are used to determine the orientation _Lx of the proximal point 316 relative to the position L ₀ , the other orientation data from controlling movement of the instrument carrier 306 along the insertion table 308 . One or more actuators and/or one or more orientation sensors associated with instrument holder 306 and/or insertion station 308 . In some examples, the orientation _Lx may be further used as an indicator of the distance or insertion depth that the distal end 318 of the elongated device 310 is inserted into the passageway of the patient P's anatomy.

4 is an isometric cross-sectional view of a distal portion of a medical device system 350 (eg, medical device system 200 ) including an imaging instrument 352 (eg, medical device 352 ) positioned within a lumen of a catheter 354 (eg, elongated device 202 ) instrument 226), wherein the distal end of the imaging instrument 352 is seated within the distal portion of the catheter 354. In the fully seated configuration, the distal end of the imaging instrument 352 abuts the distal tip 356 of the catheter 354 to provide an at least partial seal to restrict fluid and tissue from entering the catheter 354 . In some examples, imaging instrument 352 may be seated in a configuration such that the distal end of imaging instrument 352 is spaced a small distance from the proximal side of distal tip 356 of catheter 354 . This spacing helps to form a good effect on the partial seal. The distal tip of the catheter 354 and/or the distal end of the imaging instrument 352 may be shaped to provide an orifice such as a slot, cut, opening, or channel 358 that allows fluid to pass from the conduit between the lumen surface of the catheter and the outer surface of the imaging instrument. The flow path 360 discharges to the distal region of the imaging instrument. The orifices 358 may vary in shape, size, and/or number, such that multiple orifices increase the volume of fluid delivered and the amount of fluid that comes into contact with contaminants. The orientation of the plurality of orifices can be optimized radially and circumferentially to provide effective cleaning based on the fluid volume, for example, the plurality of orifices can be circumferentially spaced to create a complete concentric gap between the catheter distal tip 356 and the imaging instrument 352 . This medical device is described in more detail in US Patent Application No. 15/508,923, filed March 5, 2017, published "Devices, Systems, and Methods Using MatingCatheter Tips and Tools," which is hereby incorporated by reference. is incorporated into this disclosure in its entirety.

The channel 358 of the medical device system 350 can be used to provide a cleaning fluid including a liquid or gas, such as saline, water, carbon dioxide, oxygen, nitrogen, air, or a combination of gas and liquid (eg, saline and air) in a mist form, at the distal end of the imaging instrument, to remove debris from imaging instrument lenses and to clear visual field obstructions. In other embodiments, the fluid may be delivered to the vent via, for example, a vent, a dedicated conduit conduit for a medical instrument or vision system, other instruments in the surgical workspace, or other vent orifice configurations created by mating an instrument with a catheter. The distal tip of the imaging instrument. As the delivered clean fluid is expelled into the patient's anatomy, the volume, pressure and/or flow rate of the fluid expelled may be limited to prevent injury to the patient's anatomy. For example, if the medical device system is used in a pulmonary airway, the volume, pressure, and/or flow rate of the expelling fluid may be limited to avoid rupture of the airway in which the device is located or to prevent pneumothorax. The amount of fluid discharged, the duration of each discharge, the velocity of each discharge, the compressibility of the discharged fluid, the volume of the fluid path from the source to the discharge, and the size of the discharge orifice are examples of variables that may affect the volume of discharged fluid. As fluid drains through flow path 360 and channel 358 of medical device system 350 as shown in FIG. 4, a predictable drain volume can be determined based on proper seating of the distal end of the imaging instrument within the distal end of the catheter. When the imaging instrument is properly seated in the catheter such that a seal is formed around the imaging instrument and the distal tip of the catheter, thereby delivering cleaning fluid through channel 358 only, the expulsion volume can be controlled and predicted. When the imaging device is not sealed within the distal tip of the catheter, and the cleaning fluid can leak into the patient's anatomy around the distal end of the medical device, the discharge volume can be inconsistent and unpredictable. A predictable flow configuration for proper seating of the imaging instrument in the catheter can be used to avoid the release of damaging amounts of fluid that could harm the patient. While a seated and sealed imaging instrument is useful for predicting the expulsion of cleaning fluids, the medical device system can also be configured to allow the imaging instrument to be pulled back from the seated and sealed orientation to determine if the catheter tip is facing the anatomical wall or if it is blocked by debris blocked. A positive seating mechanism, such as a spring-loaded mechanism, can apply a force to bias the imaging instrument toward the seated and sealed configuration, but the force can be overcome by user intervention to allow the imaging instrument to be pulled back from the catheter tip.

In various embodiments, eg, in lung anatomy, the orientation and/or orientation of the catheter distal tip relative to the airway wall may be known (eg, from registration with a preoperative anatomical model or from imaging performed during the procedure) or sensed (eg, based on a force sensor) to determine whether the distal tip is abutting against the airway wall. If the distal tip rests against or has a threshold distance from the airway wall, steps can be taken to prevent emphysema or pneumothorax. For example, the operator can be alerted, fluid discharge can be inhibited, different compressibility can be delivered (eg, mist or liquid instead of gas can be delivered), fluid discharge velocity can be varied, or based on known or sensed orientation Or oriented to discharge a lower volume of fluid. The lower volume can be scaled according to the measured or calculated distance from the airway wall.

5 illustrates a fluid delivery system 400 that can be used for a variety of purposes, including delivering predictable fluid drainage, assessing flow resistance in a medical device system, and calibrating fluid drainage. System 400 includes fluid source 402 , regulator 404 , valve system 406 , fluid reservoir 408 , pressure sensor 410 , restrictor 412 , valve system 414 , flow sensor 416 and drain 417 . Flow sensors may include flow meters, pitot tubes, or equivalent sensors. The components of the fluid delivery system may be coupled by tubing 403 or other piping material. One or more components of fluid delivery system 400 may be omitted. In alternative embodiments, valve system 414 may include more than one valve, with each valve opening and closing independently or in unison to provide the fast response needed to achieve precise discharge duration and velocity.

Fluid delivery system 400 may be coupled to medical device system 420 (eg, device system 104 ) via tubing 442 that delivers fluid from fluid delivery system 400 to medical device system 420 . As shown in FIG. 6, the medical device system 420 includes an elongated flexible guide instrument or conduit 426 (eg, conduits 216, 354) through which an imaging instrument 431 (eg, imaging instrument 352) extends.

Imaging system 419 (eg, imaging system 231 ) may be coupled to imaging instrument 431 by cable 440 and instrument coupler 430 . Imaging coupler 430 is coupled to catheter port 438 as imaging instrument 431 extends through elongated flexible guide instrument 426 . Catheter housing 432 is coupled to the proximal end of elongated flexible guide instrument 426 . Imaging instruments extending in elongated flexible guide instrument 426 may be communicatively coupled to the processor of imaging system 419 by cables 440 that transmit power, image data, command signals, and the like. Imaging coupler 430 also couples fluid delivery system 400 to the proximal end of elongated flexible guide instrument 426 through coupler 430 and catheter port 438 .

The fluid delivery system 400 can be used to deliver liquids, gases, or a combination of liquids and gases. In the alternative embodiment shown in Figure 11, the fluid delivery system 400 may also include a pneumatic cuff system 443 to control the distribution of the liquid. In the embodiment of FIG. 11 , reservoir 408 is located between valve 414 and medical device system 420 . Pneumatic cuff system 443 includes a pneumatic cuff membrane inserted into reservoir 408 such that air pressure applied to pneumatic cuff system 443 from one side of valve 414 in an energized state causes fluid within reservoir 408 to be pushed out to line 442 to be delivered to the medical device system 420 . In this embodiment, when valve 414 is deactivated, excess pneumatic cuff pressure will be released through flow sensor 416 and fluid flow to medical device 420 via line 442 will cease. Using this delivery method, the dispensed fluid can be measured using the differential pressure measured over time via the known restrictor 412. These measurements can be used to calculate the flow and volume released to the pneumatic cuff system 443 . Using flow and volume measurements and the pressure within the pneumatic cuff, the volume of fluid displaced in the reservoir can be approximated. Additionally, a flow meter can be used to calculate the displacement volume when releasing excess gas from the pneumatic cuff after an energization cycle. In alternative embodiments, a combination of liquid and gas may be delivered using fluid delivery system 400 to deliver gas and a syringe (not shown) coupled to instrument coupler 430 to deliver liquid. In one example, the gas and liquid can be delivered in the form of a mist at the same time. In another example, gas and liquid delivery can occur independently in an alternating fashion.

One or more calibration techniques for calibrating fluid discharge can be used to improve accuracy and consistency. One factor used when calibrating discharge may be actuation timing. For example, over a delivery valve opening time ranging from 3ms to 60ms, the ratio between the volumetric discharge calculated by the pressure drop and the volumetric discharge measured by the discharge can be recorded. This ratio can be used to provide a multiplier for the flow meter reading. Another factor in calibrating discharge can be the absence of flow offset. Under no-flow conditions, the type of fluid discharged can affect the meter's raw offset signal count. Offset compensation can be determined for different types of media, including carbon dioxide and air. Another factor in calibration discharge is variation in idle time. After a system idle period, the ejection volume is usually in error high. Therefore, measurements can be compensated based on previous system idle time.

7 illustrates a method 500 of providing controlled fluid delivery to a medical device system 420 using components of the fluid delivery system 400 to clean the distal end of an imaging instrument. Method 500 is shown in FIG. 8 as a set of operations or processes. Not all of the processes shown may be performed in all embodiments of method 500 . Additionally, one or more processes not explicitly shown in FIG. 8 may be included before, after, between, or as part of the illustrated process. In some embodiments, one or more processes of method 500 may be implemented, at least in part, in the form of executable code stored on a non-transitory, tangible, machine-readable medium when one or more processors (eg, , the processor of the control system 112 ), when executing the executable code, may cause one or more processors to perform one or more processes.

In process 502, a reservoir 408 of known size and container volume is charged to a known or measurable volume and/or pressure. More specifically, valve system 406 may be driven to an open orientation to allow fluid to flow from fluid source 402 to reservoir 408 . In various embodiments, the fluid source may be a tank containing fluids such as brine, carbon dioxide, oxygen, nitrogen, water, compressed air, or a combination of fluids such as brine and carbon dioxide or brine and compressed air. For example, the fluid source may be a high pressure air tank placed on a movable cart in a surgical environment. The air pressure in the air tank may be about, for example, 2000 psi. The regulator 404 may regulate the pressure of the fluid passing through the valve system 406 to the working pressure. For example, the regulator may regulate the air pressure flowing from the high pressure air tank to a working pressure of approximately between 10-150 psi. In one embodiment, the regulated pressure may be 145 psi. The pressure sensor 410 may provide a reading of the pressure in the reservoir 408 of known size in order to calculate the volume of fluid at atmospheric pressure.

In process 504 , valve system 414 is driven to an open position to allow fluid to flow from reservoir 408 to medical device system 420 . In process 506 , after a predetermined time, valve system 414 is actuated to a closed orientation to terminate fluid flow from reservoir 408 to medical device system 420 and allow flow from medical device 420 to flow sensor 416 and vent 417 flow. As a safety precaution, optimality at the distal tip of catheter 426 may be limited based on factors including, but not limited to, the size of the anatomical channel into which catheter 426 is inserted, the health of the patient, and the location within the patient's anatomy (eg, proximity to the lung pleura). Volume, pressure and/or flow rate. As a safety precaution, the volume of fluid expelled (between processes 504 and 506 ) may be limited to a short predetermined period of time (eg, approximately 5-100 milliseconds) to prevent patient injury. The amount of fluid discharge and the duration of each discharge can be calibrated and controlled to limit the overall maximum fluid discharge. For example, in various embodiments in a human lung, a total maximum fluid volume of about 10 cc may be expelled by a series of small fluid drainages, although this maximum may depend on fluid type and drainage rate. In various embodiments, the target volume per expulsion (eg, a single air puff) may be 1-2 cc. Therefore, 2-3 1cc volumes are allowed to be drained before the total maximum fluid volume of 10cc is drained.

At process 508, it is determined whether sufficient fluid has been drained through the distal end of catheter 426 of medical device system 420. For example, the determination may be based on whether a predetermined number of expulsions of a predetermined volume have occurred, whether the operator determines that the obstacle has been cleared from the field of view, or whether the obstacle has been cleared from the field of view based on image processing analysis. Examples of image processing analysis are US Patent No. 15/503,589, filed February 13, 2017, publication "Systems and Methods for Cleaning an Endoscopic Instrument" and publication "Systems and Methods for Cleaning a Minimally Invasive Instrument", filed June 6, 2013 It is discussed in more detail in US Patent Application 13/911,705, each of which is incorporated herein by reference in its entirety.

At process 510, if sufficient fluid has been drained, further draining is terminated. At process 512, if not enough fluid is drained through the distal end of conduit 426 of medical device system 420, it is determined whether additional fluid is allowed to drain. At process 514, if additional fluid is not allowed to drain, the catheter may be retracted or otherwise repositioned before retrying the catheter cleaning procedure. In another embodiment, further discharges may be terminated for an extended time (eg, 30 seconds). Routine 500 may be repeated from process 502 if additional fluid discharge is allowed.

FIG. 9 illustrates a method 520 of tracking the volume of fluid expelled from the medical device system 420 using the flow sensor 416 . Method 520 is shown in FIG. 9 as a set of operations or processes. Not all illustrated processes may be performed in all embodiments of method 520 . Additionally, one or more processes not explicitly shown in FIG. 9 may be included before, after, between, or as part of the illustrated process. In some embodiments, one or more processes of method 520 may be implemented, at least in part, in the form of executable code stored on a non-transitory, tangible, machine-readable medium, when executed by one or more processors The code, when executed (eg, by a processor of the control system 112), may cause one or more processors to perform one or more processes.

At process 502, the reservoir 408 is charged to a known or measurable volume and/or pressure, as previously described. As previously described, in process 504 , valve system 414 is driven to an open position to allow fluid to flow from reservoir 408 to medical device system 420 . As previously described, in process 506 , after a predetermined time, valve system 414 is actuated to the closed orientation to terminate fluid flow from reservoir 408 to medical device system 420 . The valve system 414 may include a valve system with two flow modes. When actuated to the open position, the first flow mode of the valve or valve system allows fluid to flow from the reservoir 408 to the medical device system 420, while the second flow mode allows fluid to flow from the medical device system 420 through the flow sensor 416 and through the drain Port 417 vents to atmosphere. Thus, any excess fluid in the medical device can be measured and evacuated through drain 417 .

In process 522 , the volume of exhaust fluid released through exhaust port 417 may be measured by flow sensor 416 . In process 524, the volume of fluid expelled (and thus effectively into the patient's anatomy) via the distal end of the catheter 426 of the medical device system 420 is determined.

More specifically, the volume of fluid expelled at the distal end of conduit 426 of medical device system 420 can be determined by comparing the volume of expelled fluid measured at flow sensor 416 to the known volume and/or pressure in reservoir 408 prior to opening valve system 414 and It is determined from the measured pressure in the reservoir 408 after closing the valve system 414 . FIG. 7 is a graph 450 illustrating pressure changes in the fluid reservoir 408 of the fluid delivery system 400 . At time tl, valve system 406 is actuated to fill reservoir 408 with a measurable and thus known volume and/or pressure. In various embodiments, a pressure of about 145 psi can be maintained in the filled reservoir. After the reservoir 408 is charged, the initial fluid pressure in the reservoir is maintained until the valve system 414 is actuated at time t2. The valve system 414 may be actuated for a precise duration 460 that is calibrated to correspond to the expected discharge rate, pressure and/or volume of the medical device system 420 . The calibration time may be based on the desire that the medical device system 420 has a consistent/repeatable flow configuration in which the imaging device seals against the conduit 426, allowing only fluid to flow through the wash tank only. At time t3, valve system 414 is actuated, causing fluid flow from reservoir 408 to instrument system 420 to cease. In another embodiment, the pressure in the reservoir is monitored while the valve system 414 is open, and the valve system 414 is closed whenever the measured pressure falls below a predetermined threshold. The pressure in the reservoir 408 after the fluid is released can be measured as the final reservoir pressure (eg, by the pressure sensor 410 ), so the pressure drop 458 can be determined. The volume of fluid released from reservoir 408 may not be fully drained through medical device system 420 because a portion of the fluid may be drained through drain 417 . In process 524 of FIG. 8 , the volume of fluid expelled through the distal end of catheter 426 of medical device system 420 may be determined as the volume of fluid released from reservoir 408 measured by flow sensor 416 and the volume of fluid expelled through vent 417 difference between. In various embodiments, a pressure sensor may be used as a replacement for a flow sensor. The volume of fluid released from reservoir 408 can be determined as:

Release volume = ((initial reservoir pressure) - (final reservoir pressure)) x (reservoir volume)/(atmospheric pressure). Optionally, the calculated drain fluid volume may be compared to a threshold safe drain volume. The threshold safe drainage volume may be the maximum safe fluid volume that can be drained into the patient's anatomy without causing over-distention of the anatomical passage, pneumothorax, emphysema, or other damage to the patient's anatomy. Optionally, a warning indication may be issued to the operator if a threshold safe drainage volume is exceeded, or the control system may provide a delay before allowing subsequent fluid drainage. A measured discharge volume exceeding a threshold may indicate inconsistent or unpredictable flow that may be caused by mis-seating of the imaging instrument within the catheter or other factors. Other factors include, but are not limited to, a leak somewhere distal to valve 406 in air system 400 or instrument system 420, contamination of fluid channel 360 by patient or other fluids, damage to catheter instruments or visual instruments causing fluid fluid channel 360 to kink, or blocked.

In methods 500 and 520, an optional flow restrictor 412 between the reservoir 408 and the medical device system 420 may be used to prevent leakage of large amounts of fluid (beyond a threshold safe discharge) when draining from the medical device system 420. In some embodiments, the restrictor may be a glass capillary that restricts the flow by about 50%. If an adequately sized flow restrictor is placed in the fluid flow path, even the gap created by a mis-seated imaging instrument will not allow a volume of fluid that exceeds a threshold safe drain within the allowable activation time of valve 414 to be expelled. The optional restrictor also helps reduce the total volume used and makes it easier to measure the volume dispensed by controlling the flow rate.

FIG. 10 shows a method 560 of evaluating flow resistance in a medical device system 420 . Method 560 is shown in FIG. 10 as a set of operations or processes. Not all illustrated processes may be performed in all embodiments of method 560 . Additionally, one or more processes not explicitly shown in FIG. 10 may be included before, after, between, or as part of the illustrated process. In some embodiments, one or more processes of method 560 may be implemented, at least in part, in the form of executable code stored on a non-transitory, tangible, machine-readable medium, when executed by one or more processors The code, when executed (eg, by a processor of the control system 112), may cause one or more processors to perform one or more processes.

The medical device system 420 operates optimally with repeatable flow resistance when the imaging device is properly seated and sealed within the catheter. If the evaluation of the method 560 determines that the flow resistance exceeds or does not meet a predetermined threshold of flow resistance, a mis-seating or mis-seal of the imaging instrument with the catheter may be indicated.

At process 562, the reservoir 408 is charged to a known or measurable volume and pressure, as previously described. At process 564 , valve system 414 is actuated to an open orientation to allow fluid to flow from reservoir 408 to medical device system 420 for a short test duration, thereby releasing the test fluid volume to medical device system 420 . The test duration can be selected to ensure that the volume released from the reservoir does not exceed a safe discharge volume (eg, 1 cc of fluid) even under minimal flow resistance conditions. In one example, the test duration may be 5-10 milliseconds. In one example, the test duration may be approximately 7 milliseconds based on the minimum activation time of the valve. Depending on the size of the restrictor chosen and the amount of resistance created by the orifice 358, this time can be longer than 10 milliseconds. For example, the released volume may be between 0.25 and 1.5 cc. In some embodiments, the resistance and activation time can be calibrated to limit the volume to less than 1.5-2 cc.

At process 566 , the volume of vent fluid released through vent 417 may be measured by flow sensor 416 , as described in process 522 . At process 568 , the volume of fluid expelled through the medical device system 420 (thereby effectively entering the patient's anatomy) is determined, as described in process 524 . At process 570, the control system determines whether the expelled fluid volume exceeds an expected threshold of between 0.25cc and 0.7cc associated with a properly seated imaging instrument in the catheter. In process 572, if the fluid displacement volume exceeds or does not reach the expected threshold, the control system provides a warning indicating that the imaging instrument should be reseated in the catheter. The evaluation method 560 may be repeated until the volume of fluid expelled does not exceed the expected threshold.

One or more elements of an embodiment of the invention may be implemented in software to execute on a processor of, for example, a computer system that controls the processing system. When implemented in software, the elements of an embodiment of the invention are essentially code segments that perform the necessary tasks. The program or code segments may be stored in a processor-readable storage medium or device and may be downloaded by means of a computer data signal embodied in the form of a carrier wave over a transmission medium or communication link. A processor-readable storage device may include any medium capable of storing information, including optical media, semiconductor media, and magnetic media. Examples of processor-readable storage devices include electronic circuits; semiconductor devices, semiconductor storage devices, read only memory (ROM), flash memory, erasable programmable read only memory (EPROM); floppy disks, CD-ROMs, optical disks , hard disk or other storage devices, you can download code segments through a computer network (such as the Internet, Intranet, etc.).

Note that the processes and displays presented may not be inherently related to any particular computer or other apparatus. Various general-purpose systems may be used with programs in accordance with the teachings herein, or it may prove convenient to construct more specialized apparatus to perform the described operations. The required structure for a variety of such systems will appear as elements in the claims. Furthermore, embodiments of the present invention are not described with reference to any particular programming language. It should be understood that various programming languages may be used to implement the teachings of the present invention as described herein.

While certain exemplary embodiments of the invention have been described and illustrated in the accompanying drawings, it is to be understood that these embodiments are merely illustrative and not restrictive of the broader invention and that the embodiments of the invention are not limited to those shown. and the specific structures and arrangements described, as various other modifications may occur to those skilled in the art.

Claims (22)

1. A method for controlling fluid delivery to a catheter, the method comprising: filling a reservoir of known size with fluid to a volume with initial fluid pressure; releasing a release fluid volume of the fluid from the reservoir to the conduit; measure the volume of the discharged fluid; and From the released fluid volume and the exhausted fluid volume, the exhausted fluid volume through the conduit is determined. 2. The method of claim 1, wherein the volume of fluid discharged has atmospheric pressure. 3. The method of claim 1, wherein releasing at least a portion of the fluid from the reservoir to the conduit comprises actuating a valve for a duration calibrated to correspond to an expected discharge volume. 4. The method of claim 1, wherein releasing the fluid from the reservoir to the conduit comprises actuating a valve that passes the release fluid volume therethrough. 5. The method of claim 4, wherein the exhaust fluid volume passes through the valve. 6. The method of claim 1, wherein releasing the release fluid volume of the fluid from the reservoir to the conduit comprises passing the fluid through a flow restrictor. 7. The method of claim 1, further comprising: The released fluid volume from the reservoir is determined from the initial fluid pressure and the final fluid pressure within the reservoir after releasing the released fluid volume. 8. The method of claim 1, further comprising: It is determined whether the exhaust fluid volume exceeds a threshold. 9. The method of claim 8, further comprising: A warning indication is provided if the exhaust fluid volume exceeds the threshold. 10. The method of claim 8, further comprising: If the drained fluid volume exceeds the threshold, release of additional fluid volume from the reservoir is prevented. 11. The method of claim 8, further comprising: In response to determining that the instrument within the conduit has been moved after releasing the release fluid volume, a second release fluid volume is released and a second drain fluid volume is determined. 12. A system for controlling fluid delivery to a catheter, the system comprising: a fluid reservoir of known size and filled with fluid to an initially known volume of fluid having an initial fluid pressure; a valve system coupled between the fluid reservoir and the conduit; exhaustion hole; a flow sensor coupled between the valve system and the vent; and A control system including one or more processors configured to: actuating the valve system to release a release fluid volume of the fluid from the fluid reservoir to the conduit; measuring the volume of exhaust fluid passing through the exhaust port with the flow sensor; and From the release fluid volume and the exhaust fluid volume, a drain fluid volume of fluid drained through the conduit is determined. 13. The system of claim 12, wherein activating the valve system comprises opening the valve system for a duration calibrated to correspond to an expected discharge volume. 14. The system of claim 12, wherein the exhaust fluid volume passes through the valve system. 15. The system of claim 12, wherein the valve system includes at least two valves. 16. The system of claim 12, wherein the valve system includes a valve configured to function as a three-way valve. 17. The system of claim 12, further comprising a flow restrictor coupled between the fluid reservoir and the valve system, wherein the flow restrictor restricts the release fluid volume. 18. The system of claim 12, wherein the control system is further configured to: The released fluid volume is determined from the initial known fluid volume, the initial fluid pressure, and the final fluid pressure within the fluid reservoir after releasing the released fluid volume. 19. The system of claim 12, wherein the control system is further configured to: It is determined whether the exhaust fluid volume is above or below a threshold. 20. The system of claim 19, wherein the control system is further configured to: A warning indication is provided if the exhaust fluid volume exceeds the threshold. 21. The system of claim 19, wherein the control system is further configured to: If the drained fluid volume exceeds the threshold, release of additional fluid volume from the fluid reservoir is prevented. 22. The system of claim 19, wherein the control system is further configured to: In response to determining that the instrument has moved in the conduit after releasing the release fluid volume, a second release fluid volume is released and a second drain fluid volume is determined.

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